It has been known within the field of the specialty that heart failure is a result of the increase of the venous return which causes volume overload and severe pulmonary congestion; so that the decrease of venous return (normalization) is crucial in the improvements of the symptoms of said pulmonary congestion and heart failure. In early attempts to solve the problem, bloodletting and tourniquet in the lower extremities were used as a means to normalize venous return, to improve the pulmonary congestion.
In later years, the use of mercurial diuretics started, then stronger ASA diuretics, furosemide and bumetanide helped to rapidly decrease the venous return, with improvements of the heart failure symptoms; however, there were deleterious effects on the renal function, such as hydro-electrolytic disorders and renal damages.
The persistence of the problem of the increased venous return led to the use of nitride and nitrates, which produce a venous dilatation, causing a reduction on the venous return, improving the symptoms for a short period of time; but the inherent intolerance in this type of medication causes the loss of the effect in a few months, with the additional inconvenience of associated headaches as side effects, as it was observed in a large percentage of patients, resulting in risks of the use of these medicines during extended periods of time.
After the introduction of receptor blockers of aldosterone (spironolactona), hydro saline retention was minimized, as well as venous return; however, the receptor blockers produced serious side effects.
Later on, a new pharmacological alternative was introduced in the form of drugs that block the formation of angiotensin, which produced the decrease of venous return, improving the quality of life of a patient with heart failure.
Subsequently, the use of beta blockers of the last generation type (carvediol) was advocated, and the same produced significant benefits in patients with heart failure, being a treatment choice for a high number of patients with heart failure.
With the advent of receptor blockers (V1-V2) of the neuro-hormonal arginine-vasopressin axis (type Tolvaptan, Conivaptan), a reducer of corporal water, decrease of venous return and improvement of pulmonary congestion is achieved for a very short period of time and at an extremely high price.
The proposal to use stem cells for the treatment of heart failure was assessed at the Annual Meeting of The American Heart Association 2007. It was considered then that this technique caused little improvement in the ejection fraction of the left ventricle; and better results are obtained only when the venous return is diminished through diuretic administration.
There is no similar method to that described in this invention to treat and improve heart failure. At a device level, there are only inflatable balloons for temporary use during an invasive procedure as used in U.S. Patent No. 2003/0208232 to Blaeser et al. (Blaeser) and in U.S. Patent No. 2006/0074399 to Bates (Bates).
It is evident that effective management of the venous return is very important in improving the left ventricle function.
Lastly, in those extreme cases where known medical therapeutic measures fail, mechanical methods are used to normalize the venous return via extraction of corporal water, as the dialysis and ultra-filtration, which, although they enable good effects, in the symptoms of a congestive heart failure, this is for a short period; and the body water come backs to a state of increased venous return, causing the symptoms of pulmonary congestion and low cardiac output to reappear.